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4D-125 in Patients With X-Linked Retinitis Pigmentosa (XLRP)

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 21, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study sites: 7 to 8v15
  2. Re-verified, no change to tracked fieldsv14
  3. Study sites: 8 to 7v13
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 43 to confirmed 21 · Site details revised at 8 of 8 sitesv12 Show 2 more changesShow less
    • Enrollment target: estimated 43 to confirmed 21
    • Site details revised at 8 of 8 sites
  5. Primary endpoint revisedv11 See this version in full on ClinicalTrials.gov ↗
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 7 to 8v10
  2. Site contacts updated at 1 of 7 sitesv9
  3. Study sites: 6 to 7 Primary completion date: Apr 2026 to Jun 2026 · Completion date: Sep 2026 to May 2029 · Study description expanded, about 6 wordsv8 Show 3 more changesShow less
    • Primary completion date: Apr 2026 to Jun 2026
    • Completion date: Sep 2026 to May 2029
    • Study description expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv7
  5. Primary completion date: Mar 2024 to Apr 2026 Completion date: Sep 2024 to Sep 2026 · Eligibility criteria revisedv6 Show 2 more changesShow less
    • Completion date: Sep 2024 to Sep 2026
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  6. Primary completion date: Mar 2023 to Mar 2024 Completion date: Sep 2023 to Sep 2024 · Study description expanded, about 17 wordsv5 Show 2 more changesShow less
    • Completion date: Sep 2023 to Sep 2024
    • Study description expanded, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  7. Site contacts updated at 4 of 6 sitesv4
  8. Primary endpoint revised Enrollment target: 37 to 43 · Eligibility criteria expanded, about 60 words · Site details revised at 3 of 6 sites · 1 morev3 Show 4 more changesShow less
    • Enrollment target: 37 to 43
    • Eligibility criteria expanded, about 60 words
    • Site details revised at 3 of 6 sites
    • Study arms: 4 to 3

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 5 to 6 Study title shortened, about 4 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 1/2 multicenter study with two parallel parts: an observational natural history cohort and an open-label, prospective interventional trial in males with non-syndromic X-linked retinitis pigmentosa (XLRP) due to mutations in the gene encoding retinitis pigmentosa GTPase regulator (RPGR).
Trial Details
NCT Number NCT04517149
Lead Sponsor 4D Molecular Therapeutics
Conditions X-Linked Retinitis Pigmentosa
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov